American CryoStem Granted IRB Approval for Adipose Derived Stem Cell Processing Protocols
July 10 2013 - 8:30AM
American CryoStem Corporation (OTCQB:CRYO), a
leading strategic developer, marketer and global licensor of
patented adipose tissue-based cellular technologies for the
Regenerative and Personalized Medicine industries, today announced
that its protocols for the processing of Stromal Vascular Fraction
(SVF) and culturing of mesenchymal stem cells from autologous
adipose tissue have been approved by the Institutional Review Board
(IRB) of the International Cell Surgical Society (ICSS).
The two protocols are titled: 1) Autologous Adipose
Tissue-Derived Stromal Vascular Fraction (SVF) Containing Adult
Stem Cells with Isolation of SVF and 2) Culturing of Adipose
Derived Stem Cells (ADSCs) For Use in Institutional Review Board
Studies. These protocols provide appropriate testing methods
necessary to move the clinical investigative process towards
uniform treatments, and the collection of cGMP processing and
outcome data required by prevailing FDA regulations and guidance
for approval of regenerative cellular therapies, including potency
(cell count), contamination testing and cell viability.
The Company will make available its processing services
utilizing the IRB approved protocols to physicians and clinical
researchers for inclusion in their studies. By adopting these
protocols and the laboratory services of American CryoStem,
researchers can focus their resources on application development
rather than creating, validating and managing a clinical laboratory
for processing tissue and cellular samples. These protocols do not
involve actual human clinical trials, but affords the IRB the
opportunity to endorse standardized and validated processing
methodologies for the isolation of SVF and for tissue culture
expansion of ADSCs obtained from SVF.
The ICSS IRB thoroughly evaluated every step of American
CryoStem's processing protocols, which serve to isolate the SVF or
ADSCs from a patient's adipose tissue. The objective of
the IRB is to assess these protocols to ensure the highest patient
safety possible and to minimize the risks for those participating
in innovative research and investigational studies.
"The purpose of obtaining IRB approval of our processing
protocols is to make it easier for physicians to study the safety
of SVF and ADSCs using a standardized processing methodology that
characterizes, as well as tests the sample for sterility and
viability," stated John S. Arnone, Chairman and CEO of American
CryoStem Corporation.
The ICSS IRB is comprised of medical and scientific experts as
well as informed community members. The IRB is registered with the
Office for Human Research Protections (OHRP), a part of the U.S.
Department of Health and Human Services. The IRB, managed by
International Cell Surgical Society, is a California based
physician organization dedicated to education, advancing research
and advocating for cell-based regenerative medicine.
"In view of the extraordinarily rapid and extensive use of
Adipose Derived Stem Cells clinically, it is imperative that
standards for processing and identification of these cells be
established along with cGMP data collection to assure that the
cells used in the patients' treatments are in fact SVF or ADSCs,"
stated David Audley, Chairman of International Cell Surgical
Society.
For more information please contact
info@americancryostem.com or call us directly at
732-747-1007.
About American CryoStem Corporation
A pioneer in the fields of Regenerative and Personalized
Medicine, American CryoStem is a developer, marketer and global
licensor of patented adipose tissue-based cellular technologies and
related proprietary services with a focus on clinical processing,
commercial bio-banking and application development for adipose
(fat) tissue and autologous adipose-derived regenerative cells
(ADRCs). The Company maintains a strategic portfolio of
intellectual property and patent applications that form its Adipose
Tissue Processing Platform, which supports and promotes a growing
pipeline of biologic products and processes, clinical services and
international licensing opportunities. Through its ACS
Laboratories division, the Company operates an FDA registered, cGMP
compliant human tissue processing, cryo-storage, cell culture and
differentiation media development facility in Mount Laurel, New
Jersey.
For more information, please visit
www.americancryostem.com and
www.acslaboratories.com.
This press release may contain forward-looking statements,
including information about management's view of American CryoStem
Corporation's ("the Company") future expectations, plans and
prospects. In particular, when used in the preceding
discussion, the words "believes," "expects," "intends," "plans,"
"anticipates," or "may," and similar conditional expressions are
intended to identify forward-looking statements. Any
statements made in this press release other than those of
historical fact, about an action, event or development, are
forward-looking statements. These statements involve known and
unknown risks, uncertainties and other factors, which may cause the
results of the Company, its subsidiaries and concepts to be
materially different than those expressed or implied in such
statements. Unknown or unpredictable factors also could have
material adverse effects on the Company's future results. The
forward-looking statements included in this press release are made
only as of the date hereof. The Company cannot guarantee
future results, levels of activity, performance or
achievements. Accordingly, you should not place undue reliance
on these forward-looking statements. Finally, the Company
undertakes no obligation to update these statements after the date
of this release, except as required by law, and also takes no
obligation to update or correct information prepared by third
parties that are not paid for by American CryoStem Corporation.
CONTACT: Hanover|Elite
Kathy Addison, Chief Operating Officer
407-585-1080 or via email at CRYO@hanoverelite.com
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